NIKOPrep

Basic Information

• Brand Name: NIKOPrep
• Primary DI: 10853512006711
• Version / Model: 2121
• Catalog Number: 2121
• Company Name: NIKOMED USA
• Labeler DUNS: 073648341
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 1
• Public Version Date: 2020-06-16
• Public Version Status: New
• Public Device Record Key: 95e2e4c5-4cc9-4999-8594-5e3a1b624966

Device Description

Strips for Skin Preparation

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47102	Electrode skin abrasion pad	A small, abrasive, hand-held device intended to be rubbed over select skin surface areas of a patient in preparation for placement of electrocardiograph (ECG) electrodes. It is used to remove superficial skin cells to enhance electrical contact (conductivity) for optimal ECG signals. It is typically used by emergency medical services (EMS). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00853512006714	GS1
Primary	10853512006711	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]